CLINICAL Study results. The efficacy and safety of BESPONSA were evaluated in a Phase 3 clinical trial vs standard chemotherapy. 1,2 There was a higher post-HSCT non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate; Hepatotoxicity, Including Hepatic VOD: Hepatotoxicity, including fatal and life-threatening VOD, occurred in 23/164 . The National Institute for Health and Care Excellence has issued draft guidelines backing restricted use of Pfizer’s Mylotarg for newly diagnosed acute myeloid leukaemia (AML), but has asked for more information on the firm’s Besponsa for a type of acute lymphoblastic leukaemia (ALL).. Of patients on Besponsa, 81 percent had complete remission, compared to only 29 percent of patients on chemotherapy, according to results published in the New England Journal of Medicine. Furthermore, Besponsa maintained remission for longer (a median of 4.6 months) than chemotherapy (3.1 months).. As a result of this the cost-effectiveness body has now recommended Besponsa, an antibody-drug conjugate, in updated final draft guidance. The decision gives a new treatment option for patients with a disease whose prognosis is poor, and for which there are few available alternative therapies.. . .